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EC number: 457-310-8
CAS number: 127733-97-5
PLATINUM(2+), TETRAAMMINE-, (SP-4-1)-, DIACETATE (9CI)
potential of a solution of tetraammineplatinum dinitrate to adversely
affect the development of CD rat pups was investigated in a reproductive
and developmental screening study conducted according to OECD Test
Guideline 421 and to GLP. The test material was administered by oral
gavage for at least 28 days. Males were dosed for 14 days pre-mating and
14 days mating/post mating. Females were dosed for 14 days pre-mating,
through gestation and up to post-partum day 3 (test day 40-47). Three
dose groups (50, 250 and 1000 mg/kg bw/day) and a control group were
used, each containing 12 animals of each sex.
(F0) animals were observed for clinical signs of toxicity throughout the
study, with body weights and food consumption monitored. At necropsy,
animals were subjected to external and internal macroscopic examinations
for any abnormalities or pathological changes. Special attention was
paid to the reproductive organs. The numbers of implantation sites and
corpora lutea were recorded. Histopathologic examination was performed
on the ovaries, testes and epididymides of all animals in the control
and high-dose groups, with special emphasis on the qualitative stages of
spermatogenesis and histopathology of interstitial testicular structure.
On postnatal day 4, pups were carefully examined for gross abnormalities
sign of toxicity was a significantly reduced body weight in high-dose
females at the end of the study on post-partum day 4. Thus, the NOAEL
for general toxicity was deemed to be 250 mg/kg bw/day.
no developmental toxicity effect at any dose level. Thus, the NOAEL for
developmental toxicity was 1000 mg/kg bw/day, the highest dose tested.
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